Ranitidine Hydrochloride Ranitidine CAS No 66357-35-5

China Ranitidine Hydrochloride Ranitidine CAS No 66357-35-5, Find details about China 66357-35-5, Ranitidine Hydrochloride from Ranitidine Hydrochloride Ranitidine CAS No 66357-35-5

Basic Info.

Model NO.

SAMREAL-0188

Standard

USP40

Shelf Life

3 Years

Trademark

samreal

Specification

25kg/drum

Origin

China

Model NO.

SAMREAL-0188

Standard

USP40

Shelf Life

3 Years

Trademark

samreal

Specification

25kg/drum

Origin

China

Product Desciption

Ranitidine Hydrochloride CAS No 66357-35-5

Test basis	USP40	Shelf life: 3 years
Items	Specification	Results
Description	Whtie or pale yellow,crystalline powder,it shows polymorphism.	Pale yellow,crystalline powder,it shows polymorphism
Identification
IR spectrum	Obtainedspectrum consistent with ranitidine Hydrochloride CRS	Complies
UV spectrum	Absorptivities at 229nm and 315nm,calculated on the dried basis,do not differ by more than 3.0%	Complies
Chemical reaction	Should be positive reaction	Complies
Test
PH	4.5-6.0	5.7
Sulfated ash	≤0.1%	0.02%
Loss on drying	≤0.75%	0.27%
Heavy metal	≤20ppm	<20ppm
Related substance	Impurity A≤0.3%	0.112%
	Impurity J≤0.1%	0.042%
	Single unspecified impurity≤0.2%	0.023%
	Total impurities≤0.5%	0.295%
Assay	97.5%-102.0%	99.2%

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General Description

Ranitidine, N-[2-[[[5-(dimethylamino)methyl]-2-furanyl]methyl]thiol] ethyl]-N'-methyl-2-nitro-l,1-ethenediamine (Zantac), is a white solid, which inits hydrochloride salt form is highly soluble in water. It is anaminoalkyl furan derivative with pKa values of 2.7 (sidechain) and 8.2 (dimethylamino). Ranitidine is more potentthan cimetidine, but less potent than famotidine. Likeother H2-antagonists, it does not appear to bind to otherreceptors.
Bioavailability of an oral dose of ranitidine is about 50%and is not significantly affected by the presence of food.Some antacids may reduce ranitidine absorption and shouldnot be taken within 1 hour of administration of this drug. Theplasma half-life of the drug is 2 to 3 hours, and it is excretedalong with its metabolites in the urine. Three metabolites, ranitidineN-oxide, ranitidine S-oxide, and desmethyl ranitidine,have been identified. Ranitidine is only a weak inhibitor ofthe hepatic cytochrome isozymes, and recommended doses ofthe drug do not appear to inhibit the metabolism of otherdrugs. However, there have been isolated reports of drug interactions(warfarin, triazolam) that suggest that ranitidinemay affect the bioavailability of certain drugs by someunidentified mechanism, perhaps by pH-dependent effect onabsorption or a change in volume of distribution.
In addition to being available in various dosage forms asthe hydrochloride salt, ranitidine is also available as a bismuthcitrate salt for use with the macrolide antibiotic clarithromycinin treating patients with an active duodenalulcer associated with H. pylori infection. Eradication of H.pylori reduces the risk of duodenal ulcer recurrence.